NCT00660868

Brief Summary

Signal processing in the olfactory neuron could be influenced by inhibition of enzymes like phosphodiesterase. Pentoxifylline is a unspecific phosphodiesterase inhibitor. The hypothesis is that pentoxifylline could lead to increased sensitivity to odors.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 16, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 17, 2008

Completed
1.5 years until next milestone

Study Start

First participant enrolled

November 1, 2009

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

February 5, 2016

Status Verified

February 1, 2016

Enrollment Period

6.2 years

First QC Date

April 16, 2008

Last Update Submit

February 4, 2016

Conditions

Olfaction Disorders

Keywords

smellolfactionolfactory sensitivitysmell losschemoreception

Outcome Measures

Primary Outcomes (1)

  • TDI-score

    at day 0 and follow up after 3 weeks

Secondary Outcomes (1)

  • odor threshold odor discrimination odor identification

    at day 0 and at follow up after 3 weeks

Study Arms (1)

1

Patients with posttraumatic, idiopathic, and postinflammatory cause of smell loss; patients age between 18 and 50 years. Odor threshold better than 1.

Drug: Pentoxifylline retard 400mg

Interventions

Pentoxifylline retard 400mgDRUG

Agapurin retard 400mg 3/day per os for 3 weeks

Also known as: Agapurin retard
1

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

hyposmic or functionally anosmic patients TDI-score \<31; age: 18-50 years; odor threshold: better than 1; cause of smell loss: post traumatic, postinflammatory, idiopathic

You may qualify if:

  • hyposmic or functionally anosmic patients TDI-score \<31
  • age: 18-50 years
  • odor threshold: better than 1
  • cause of smell loss: post traumatic, postinflammatory, idiopathic

You may not qualify if:

  • normosmic patients,
  • patients with contraindications for application of pentoxifylline
  • patients that cannot give written agreement to the study
  • patients under 18 years and over 50 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zentrum für Riechen und Schmecken, Universitäts- HNO- Klinik Dresden

Dresden, 01307, Germany

Location

MeSH Terms

Conditions

Olfaction DisordersAnosmia

Condition Hierarchy (Ancestors)

Sensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Volker Gudziol, Dr. med.

    Technische Universität Dresden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2008

First Posted

April 17, 2008

Study Start

November 1, 2009

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

February 5, 2016

Record last verified: 2016-02

Locations

DE(1)